NDC 63304-793

Simvastatin

Simvastatin

Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ranbaxy Pharmaceuticals Inc.. The primary component is Simvastatin.

Product ID63304-793_d005a31b-31ba-400e-a75c-99e6adf745bd
NDC63304-793
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-12-20
Marketing CategoryANDA /
Application NumberANDA076285
Labeler NameRanbaxy Pharmaceuticals Inc.
Substance NameSIMVASTATIN
Active Ingredient Strength80 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 63304-793-00

1000 kg in 1 BOX (63304-793-00)
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-793-90 [63304079390]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076285
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-31
Inactivation Date2020-01-31

NDC 63304-793-10 [63304079310]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076285
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20
Inactivation Date2020-01-31

NDC 63304-793-50 [63304079350]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076285
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-31
Inactivation Date2020-01-31

NDC 63304-793-30 [63304079330]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076285
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN1000 kg/1000kg

NDC Crossover Matching brand name "Simvastatin" or generic name "Simvastatin"

NDCBrand NameGeneric Name
0093-7152SimvastatinSimvastatin
0093-7153SimvastatinSimvastatin
0093-7154SimvastatinSimvastatin
0093-7155SimvastatinSimvastatin
0093-7156SimvastatinSimvastatin
0179-0128SimvastatinSimvastatin
0179-0240simvastatinsimvastatin
0179-0241simvastatinsimvastatin
0179-0242simvastatinsimvastatin
0179-0243simvastatinsimvastatin
0179-1897SimvastatinSimvastatin
0179-1898SimvastatinSimvastatin
0179-1899SimvastatinSimvastatin
0615-6579SimvastatinSimvastatin
0615-6580SimvastatinSimvastatin
0615-6581SimvastatinSimvastatin
0615-6587SimvastatinSimvastatin
0615-6588SimvastatinSimvastatin
0615-7704SimvastatinSimvastatin
0615-7705SimvastatinSimvastatin
0615-7706SimvastatinSimvastatin
68071-1646simvastatinsimvastatin
68071-1965simvastatinsimvastatin
68071-1721simvastatinsimvastatin
68071-1711simvastatinsimvastatin
68071-2092SimvastatinSimvastatin
68071-1990simvastatinsimvastatin
68071-1699simvastatinsimvastatin
68071-1868simvastatinsimvastatin
68071-1946simvastatinsimvastatin
68071-3115SimvastatinSimvastatin
68071-3391simvastatinsimvastatin
68071-3157SimvastatinSimvastatin
68071-3289simvastatinsimvastatin
68071-4331SIMVASTATINSIMVASTATIN
68071-4504simvastatinsimvastatin
68084-512SimvastatinSimvastatin
68151-0177SimvastatinSimvastatin
68084-511SimvastatinSimvastatin
68180-481SIMVASTATINSIMVASTATIN
68180-482SIMVASTATINSIMVASTATIN
68180-465SIMVASTATINSIMVASTATIN
68180-478SIMVASTATINSIMVASTATIN
68180-480SIMVASTATINSIMVASTATIN
68180-464SIMVASTATINSIMVASTATIN
68180-479SIMVASTATINSIMVASTATIN
68382-069SimvastatinSimvastatin
68382-067SimvastatinSimvastatin
68382-065SimvastatinSimvastatin
68382-068SimvastatinSimvastatin
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